510(k) K811081
K811081 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "MEDULLARY CANAL SCRAPERS". The FDA issued a decision of Substantially Equivalent on April 29, 1981. The device falls under product code HTO (Reamer), a Class I device regulated under 21 CFR 888.4540. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1981
- Date Received
- April 21, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reamer
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type